Bacitracin
Bacitracin Zinc Ointment USP
4a9fe0fa-5549-4e06-e054-00144ff8d46c
HUMAN OTC DRUG LABEL
May 15, 2025
Trifecta Pharmaceuticals USA, LLC.
DUNS: 079424163
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bacitracin Zinc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (4)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
First Aid to help prevent infection in
- minor cuts
- scrapes
- burns
STORAGE AND HANDLING SECTION
Other Information
Store between 15º to 25ºC (59º to 77ºF)
Lot No and Expiration Dates - please see box and tube crimp
100% GUARANTEED
Distributed By:
Trifecta Pharmaceuticals USA ®
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Bacitracin Zinc 500 Units per gram
OTC - PURPOSE SECTION
Purpose
First Aid Antibiotic
WARNINGS SECTION
Warnings
For External Use Only.
**Do not use;**in eyes, over large areas of the body, if you are allergic to any of the ingredients, longer than 1 week unless directed by a doctor.
.
OTC - STOP USE SECTION
Stop Use and Ask Doctor if
- The condition persists or gets worse
- A rash or allergic reaction develops
DOSAGE & ADMINISTRATION SECTION
Directions
- Clean the affected area
- Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
- May be covered with a sterile bandage
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Aloe vera gel, light mineral oil, white petrolatum
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center immediately